Method for using percutaneous accessport

ABSTRACT

A method for both disposing an agent in a body organ, preferably a sexual organ, of a human or animal and retrieving a fluid sample containing the agent from the body organ of the human or animal, utilizing a percutaneous access port. A portion of the percutaneous access port is implanted in a body organ of the human or animal and connected to the body organ so that fluid communication exists between the body organ and the fluid chamber of the percutaneous access port, wherein the fluid chamber is not percutaneously implanted. An agent is disposed in the fluid chamber of the percutaneous access port, and flushed to the organ. At a later time, a fluid sample containing the agent is withdrawn from the fluid chamber, and the amount of the agent in the sample is determined.

This is a continuation of co-pending application U.S. Ser. No.07/560,481, filed on Jul. 24, 1990, now abandoned, entitled Method forUsing Pertucaneous Access Port which is a continuation of U.S. Ser. No.07/283,251, filed on Dec. 12, 1988, now abandoned, which is acontinuation-in-part of U.S. Ser. No. 06,845,574, filed on Mar. 28,1986, now U.S. Pat. No. 4,790,826.

FIELD OF THE INVENTION

The present invention relates generally to percutaneous access portsand, more particularly, but not by way of limitation, to a percutaneousaccess port having access ports which communicate with a fluid chamberand a transducer disposed in the fluid chamber for detecting thepressure of the fluid in the fluid chamber.

SUMMARY OF THE INVENTION

A device adapted to be partially implanted in a human, rat or otheranimal to provide continuous access to a body organ or cavity throughfluid communication. During implantation, the percutaneous access port10 is connected to a selected body organ so that the fluid chamber 14 ofthe device is in fluid communication with that organ or cavity. An upperend portion of the device extends through the skin and comprises atleast two access ports in communication with the fluid chamber.Resealable access to the fluid chamber through the access ports isprovided by a septum assembly. In a preferred embodiment, a transduceris disposed within the fluid chamber for detecting the pressure of thefluid. The selected body organ can be a sexual organ of a male orfemale. In a pregnant female subject, a fetus can be monitored by thepresent invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a sectional view of a percutaneous access port which isconstructed in accordance with the present invention.

FIG. 2 is a top view of the percutaneous access port of FIG. 1.

FIG. 3 is a sectional view of the cap portion of the base assembly shownin FIG. 1, the top of the cap being shown in FIG. 2.

FIG. 4 is a sectional view of a modified percutaneous access port whichis constructed in accordance with the present invention.

FIG. 5 is a sectional schematic view of a pregnant human uterus, showingthe connection of the percutaneous access port to the uterus and amnion.

FIG. 6 is a sectional schematic view of a non-pregnant human uterus,showing the connection of the percutaneous access port to the uterinewall.

FIG. 7 is a sectional schematic view of a human male sexual organshowing the connection of the percutaneous access port to a scrotum.

FIG. 8 is a sectional schematic view of a human male sexual organshowing the connection of the percutaneous access port to a penis.

BRIEF DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIGS. 1, 2, and 3, shown therein and designated by thegeneral reference numeral 10 is a percutaneous access port which isconstructed in accordance with the present invention. In general, thepercutaneous access port includes a base assembly 12 having a fluidchamber 14 formed in a portion thereof and having a plurality of accessports formed through a portion thereof in fluidic communication with thefluid chamber 14, two access ports being shown in FIGS. 1 and 2 anddesignated therein by the reference numerals 16 and 18. A septumassembly 20 is connected to the base assembly 12 and a portion of theseptum assembly 20 extends across each access port 16 and 18 for sealingeach access port 16 and 18, the septum assembly 20 being adapted toprovide resealable access through the septum assembly 20 to the fluidchamber via either one or both of the access ports 16 and 18. Atransducer assembly 22 is disposed in the base assembly 12 and a portionof the transducer assembly 22 is in communication with the fluid chamber14. The transducer assembly 22 is adapted to sense or detect thepressure of the fluid in the fluid chamber 14 and to provide an outputtransducer signal indicative of the pressure of the fluid within thefluid chamber 14.

The percutaneous access port 10 is adapted to be implanted in a subjectsuch as a human, rat, cow or other such animal. During implantation, thepercutaneous access port 10 is connected to a selected organ (internalbody part) or cavity in the warm blooded animal so that the fluidchamber 14 is in communication with the selected organ in the warm orcold blooded animal and an upper end portion of the percutaneous accessport 10 extends through the outer layer of skin of the animal so theupper end portion of the percutaneous access port 10 is disposed abovethe outer layer of skin in an implanted condition of the percutaneousaccess port 10, the upper layer of skin being diagrammatically shown inFIG. 1 and designated therein by the reference numeral 24. Thus, in theimplanted condition of the percutaneous access port 10, an upper endportion of the base assembly 12 extends through and above the outerlayer of skin 24 thereby providing continuous access to the selectedorgan or cavity in the subject by way of either one or both of theaccess ports 16 which are in fluidic communication with the selectedorgan or cavity by way of the fluid chamber and the connection of thefluid chamber to the selected organ or cavity and providing a continuoustransducer output signal indicative of the pressure of the fluid withinthe fluid chamber 14. The percutaneous access port 10 of the presentinvention provides quick, safe and accurate measurement of fluidpressure, particularly blood pressure, in conscious animals and isuseful in relatively small animals. In an implanted condition of thepercutaneous access port, the transducer assembly 22 provides continuoustransducer output signals indicative of the pressure of the blood orfluid in the fluid chamber 14 and, at the same time, the access ports 16and 18 provide access to the fluid chamber 14 for flushing the fluidchamber 14 or for infusion of substances into the fluid within the fluidchamber.

It particularly should be noted that the percutaneous access port 10 ofthe present invention provides a means for measuring vascular pressuresin small, conscious animals. Large animals such as dogs and cats arebecoming relatively expensive and there is growing pressure to preventmedical research from utilizing large animals such as dogs and cats.Thus, it is becoming extremely important to be able to humanely utilizerelatively smaller animals for research, and the percutaneous accessport 10 of the present invention provides a small, implantable devicefor quickly, safely and accurately measuring blood pressure without painor discomfort to conscious animals in a manner which reduces time andmaintenance during the performance of experiments on large numbers ofsuch animals. In addition, the percutaneous access port 10 can beutilized to provide chronic infusion ports for pharmacological studies,chronic sampling from vessels, organs or cavities, direct access to anyorgan or cavity (intrauterine access for artificial insemination ofcattle), for example, and other applications as will be apparent tothose skilled in the art from the following detailed description.

The base assembly 12, more particularly, has an upper end 26 and a lowerend 28 and the fluid chamber 14 is formed in the base assembly 12,generally between the upper and the lower ends 26 and 28. An inlet port30 is formed in a portion of the base assembly 12, generally near thelower end 28 thereof. The inlet port 30 is connectable to the selectedorgan or cavity by catheter, for example, and the inlet port 30 is incommunication with the fluid chamber 14 thereby providing communicationbetween the fluid chamber 14 and the selected organ or cavity. Theaccess ports 16 and 18, more particularly, extend through the upper end26 of the base assembly 12 and each of the access ports 16 and 18extends a distance through the base assembly 12 intersecting the fluidchamber 14 to provide communication between the upper end 26 of the baseassembly 12 and the fluid chamber 14. The inlet port 30 is formedthrough a lower end portion 28 of the base assembly 12 and the inletport 30 extends a distance through the base assembly 12 intersecting thefluid chamber 14, the inlet port 30 being located below the upper skin24 level in an implanted condition of the percutaneous access port 10.

The base assembly 12 more particularly, includes a lower base 32 havingan upper end 34, a lower end 36 and an outer peripheral surface 38. Aflange 40 is formed on the outer peripheral surface 38 generallyadjacent to the lower end 36 of the lower base 32 and the flange 40extends a distance radially from the outer peripheral surface 38 of thelower base 32. An opening 42 extends through the upper end 34 of thelower base 32 and the opening 42 extends a distance through the lowerbase 32 generally between the upper and the lower ends 34 and 36, theopening 42 intersecting the lower end 36 of the lower base 32, in oneembodiment as shown in FIG. 1.

The inlet port 30, more particularly, extends through the outerperipheral surface of the flange 40 and through the flange 40 andthrough the lower base 32 and intersects the opening 42 and the lowerbase 32. A portion of the opening 42 generally at the upper end 34 ofthe lower base 32 has a smaller diameter as compared to the remainingportion of the opening 42, thereby forming a sealing surface 44 in thelower base 32. The sealing surface 44 is positioned generally betweenthe upper and the lower ends 34 and 36 of the lower base 32 and thesealing surface 44 extends circumferentially about the opening 42 in thelower base 32.

The lower base 32 also includes a circularly shaped disc 46. A recess 48is formed in the wall of the lower base formed by the opening 42 and therecess 48 is positioned generally near the lower end 36 of the lowerbase 32. A ring 50 is formed on the outer peripheral surface of the disc46 and the disc 46 is sized and shaped to fit into the opening 42 in thelower base 32 to a position wherein the ring 50 snaps into the recess 48thereby securing the disc 46 in the lower base 32. The discloses theopening 42 at the lower end 36 of the lower base 32.

The percutaneous access port 10 also includes a spring 52 and a sealmember 54. The spring 52 preferably is cylindrically shaped and isconstructed of a silicone rubber material. The spring 52 has an upperend 56 and a lower end 58 and a circularly shaped recess 60 is formed inthe upper end 56 of the spring 52. The seal member 54 is sphericallyshaped and is constructed preferably of stainless steel.

In an assembled position, the spring 52 is positioned in the opening 42of the lower base 32 with the lower end 58 of the spring 52 beingsupported on the disc 48 portion of the lower base 32. The seal member54 is positioned in the recess 60 in the upper end 56 of the seal member54. The seal member 54 and the spring 52 each are sized and shaped sothat the spring 52 biases the seal member 54 into sealing engagementwith the sealing surface 44 formed in the lower base 32, the seal member54 cooperating with the sealing surface 44 to sealingly close theopening 42 in the lower base 32 when the seal member 54 sealinglyengages the sealing surface 44 in the lower base 32.

The base assembly 12 also includes a cover 62 which has an upper end 64and a lower end 66 with an outer peripheral surface 68. An opening 70 isformed through the lower end 66 of the cover 62 and the opening 70extends a distance through the cover 62 generally toward the upper end64 terminating with an upper, downwardly facing surface 72 formed intothe cover 62, the surface 72 being positioned generally near and spaceda distance from the upper end 64 of the cover 62. An upper opening 76extends through the upper end 64 of the cover 62 and the upper opening76 extends through the cover 62 intersecting the opening 70, the upperopening 76 having a diameter smaller than the diameter of the opening70.

A portion of the surface formed by the opening 70 and the cover 62 isthreaded generally near the lower end 66 of the cover 62, therebyforming a threaded portion 80. A portion of the outer peripheral surface38 of the lower base 32 also is threaded generally near the lower end36, thereby forming a threaded portion 78 on the outer peripheralsurface 38 of the lower base 32. The threaded portion 78 is sized andshaped to threadedly engage the threaded portion 80 formed on the outerperipheral surface 68 of the cover 62 in an assembled position of thepercutaneous access port 10. Thus, the cover 62 is positioned on thelower base 32 and the threaded portions 78 and 80 cooperate to securethe cover 62 to the lower base 32. In the assembled position of thelower base 32 and the cover 62, the lower end 66 of the cover 62 isgenerally adjacent the flange 40 on the lower base 32, and the upper end64 of the cover 62 extends a distance above the upper end 34 of thelower base 32. In this position, the upper end portion of the lower base32 extends a distance into the opening 70 formed in the cover 62 to aposition wherein the upper end 34 of the lower base 32 is spaced adistance from the downwardly facing surface 72 formed in the cover 62.

Two cover access ports 82 and 84 are formed through the upper end 64 ofthe cover 62, each cover access port 82 and 84 extending through theupper end 64 and through the downwardly facing surface 72 and therebyintersecting the opening 70 in the cover access 62. The cover accessport 82 preferably is positioned one hundred and eighty degrees from thecover access port 84, as shown in FIG. 2.

The base assembly 12 also includes a cap 86 which preferably iscircularly shaped. The cap 86 is positioned generally adjacent the upperend 64 of the cover 62 and the cap 86 is secured to the upper end 64 ofthe cover 62 by two screws 88 and 90, as shown in FIG. 2. Two cap accessports 92 and 94 are formed through the cap 86 and the cap access port 92is positioned one hundred and eighty degrees from the cap access port94.

In the assembled position, the cap 86 is positioned on the upper end 64of the cover 62 in a position wherein the cap access port 92 is alignedwith the cover access port 82 and the cap access port 94 is aligned withthe cover access port 84. The cap access ports 92 and 94 cooperate withthe cover access ports 82 and 84 to provide the access ports 16 and 18in the base assembly 12 and the access port 16 and 18 each are incommunication with the opening 70 and cover 62. A cable opening 96 isformed through a central portion of the cap 86, for reasons to be mademore apparent below.

The cap 86, more particularly, includes a first cap member 98 and asecond cap member 100. The first and the second cap members 98 and 100are preferably identical in construction.

The cap member 98 includes a semi-circularly shaped portion 102 which isactually larger than a half-circle shape of the entire cap 86. Thecircularly shaped portion 102 terminates in a flat edge 104. A recess106 is formed in the flat edge 104 and the recess 106 extends a distanceinto the first cap member 98 thereby forming a ledge 108.

The cap member 100 includes a semi-circularly shaped portion 110 whichis actually larger than a half-circle shape of the entire cap 86. Thecircularly shaped portion 110 terminates in a flat edge 112. A recess114 is formed in the flat edge 112 and the recess 114 extends a distanceinto the first cap member 100 forming a ledge 116.

A cable opening portion 118 is formed in the edge 104 of the first capmember 98 and a cable opening portion 120 is formed in the edge 112 ofthe second cap member 100. The cable opening portions 118 and 120 eachare sized and shaped to provide the cable opening 96 in the assembledposition of the first and the second cap members 98 and 100.

In the assembled position of the cap 86, the first cap member 98 ispositioned on the second cap member 100 so that the ledge 108 of thefirst cap member 98 is disposed in the recess 114 of the second capmember 100. The first and the second cap members 98 and 100 arepositioned so that the cable opening portion 118 is generally alignedwith the cable opening portion 120 and the cable opening portions 118and 120 cooperate and combine to form the cable opening 96 and the cap86. When a cable is extending through the cable opening 96, the capmembers can be disassembled from such cable portion or assembled on suchcable portion by merely removing the first and the second cap membersfrom such cable portion or disposing the first and the second capmembers about such cable portion.

The percutaneous access port 10 also includes a plunger 124. The plunger124 comprises a generally circularly shaped plate 126, having an uppersurface 127 and a lower surface 129, and a stem 128. One end of the stem128 is secured to a central portion of the plate 126 and the stem 128extends a distance from the plate 126 terminating with an engaging end130 a plurality of ports 132 are formed through the plate 126, the port132 being circumferentially spaced about the stem 128 and only two ports132 being shown in FIG. 1. Additionally, a port is formed through thestem 128 for the same purpose as the ports 132 with the stem 128 beingtapered so the seal member 54 does not seal such port.

In an assembled position, the transducer assembly 22 is disposed in theupper opening 76 of the cover 62 and the transducer assembly 22 issealing connected to the cover 62 in this assembled position therebyclosing the upper opening 76. One end of the transducer cable 134 isconnected to the transducer assembly 22 in the cover 62 and thetransducer cable 134 extends from the transducer assembly 22 upwardlythrough the cable opening 96 in the cap 86. The septum assembly 20 isdisposed on the upper end 64 of the cover 62 and the cap 86 is disposedon the septum assembly 20, the cap 86 being secured to the upper end ofthe cover 62 by way of the screws 88 and 90 with the septum assembly 20sealingly disposed between the cap 86 and the upper end 64 of the cover62. The septum assembly 20 also is disposed between the cap access ports92 and 94 and the aligned cover access ports 82 and 84 so the septumassembly 20 sealingly closes the access ports 16 and 18, the septumassembly 20 being adapted to provide resealable access through theaccess ports 16 and 18 to the fluid chamber 14, as mentioned before.

Cap 86 may also be used without the transducer assembly 22 to provide alarger access port to the fluid chamber 14. A septum assembly (notshown) is sealingly disposed between the cable opening 96 in the cap 86.Cable opening 96 thereby becomes a larger resealable port than accessports 16 and 18. This may be desirable if a large gauge needle is neededto inject into or withdraw from the fluid chamber 14 larger molecularagents.

An O-ring seal member 136 is disposed on the upper end 34 of the lowerbase 32, and the plate 126 of the plunger 124 is disposed on the sealmember 136 with the stem 128 of the plunger extending through a centralportion of the seal member 136 and through the opening 42 in the upperend 34 of the lower base 32. An O-ring seal member 138 is disposed onthe upper surface 127 of the plate 126. Then, the cover 62 with the cap86 connected thereto is threaded onto the lower base 32 to a positionwherein seal member 138 engages the plate 126 of the plunger 124 andforces the plunger 124 in a downward position thereby forcing the stem128 further through the upper opening 76 to a position wherein theengaging end 130 of the plunger 124 engages the seal member 54 andpushes the seal member 54 downwardly and out of sealing engagement withthe sealing surface 44 in the lower base 32. In this position, the cover62 is threadedly connected to the lower base 32, the stem 128 of theplunger 124 has moved the seal member 54 out of sealing engagement withthe sealing surface 44 in the lower base 32 thereby opening the opening42 through the lower base 32, the seal member 136 forms a seal betweenthe upper end 34 portion of the lower base 32 and the plate 126 and thecover 62, and the seal member 138 forms a seal between the upper surfaceof the plate 126 of the plunger 124 and the downwardly facing surface 72formed in the cover 62. In this assembled position, the opening 42 inthe lower base 32, the opening in the seal member 136 generally betweenthe plate 126 of the plunger 124 and the upper end 34 of the lower base32 and the opening in the seal member 138 generally between the plate126 and the downwardly facing surface 72 in the cover 62 forms the fluidchamber 14. The seal member 138 prevents the plunger 124 from damagingthe transducer assembly 22.

In the assembled position of the percutaneous access port 10, thepercutaneous access port 10 is implanted in an animal so that the lowerend portion 28 of the base assembly 12 extends below the upper surfaceof the skin 24 of the animal and the upper end 26 portion of the baseassembly 12 extends above the upper skin 24 of the animal. In thisassembled position, the access ports 16 and 18 thus are accessible fromoutside the body of the animal and thus access is provided to the fluidof chamber 14 outside the body of the animal. In addition, thetransducer cable 134 also extends from outside the body of the animal.

Preferably, a connector 140 is connected to the inlet port 30 formed inthe lower end 36 portion of the lower base 32 and the connector 140 isadapted to be connected to tubing (shown in dashed-lines in FIG. 1 anddesignated by the reference numeral 142), the tubing 142 extending fromthe inlet port 30 in the lower base 32 to the selected organ or cavityin the animal and the tubing 142 being operatively connected to theselected organ in the animal in the implanted condition of thepercutaneous access port 10. In this position, communication isestablished between the fluid chamber 14 in the percutaneous access port10 and the selected organ or cavity in the animal by way of the tubing142, the inlet port 30, the opening 42 and the lower base 32 and ingeneral, the open space between the upper end 34 of the lower base 32and the downwardly facing surface 72 of the cover 62 or, in other words,between the upper end 34, the lower base 32 and an upper end 64 portionof the cover 62, the fluid chamber 14 also being in communication withthe transducer assembly 22 in the assembled an implanted condition ofthe percutaneous access port 10.

When the percutaneous access port 10 is being utilized to monitor bloodpressure in a vessel or artery, the connector 140 is connected eitherdirectly to the vessel or artery or one end of the tubing 142 isconnected to the connector 140 in the opposite end of the tubing 142 isconnected to the selected vessel or artery, the last mentioned madebeing preferred. Blood flow in the vessel or artery then is inputtedthrough the inlet port 30 into the opening 42 and the lower base 40,through the opening 42 in the lower base 32 and into the open spacegenerally between the upper end 34 of the lower base 32 and thedownwardly facing surface 72 on the cover 62, such blood or fluid in thefluid chamber 14 also being in communication with the transducerassembly 22. Thus, in this assembled and implanted condition of thepercutaneous access port 10, the transducer assembly 22 is incommunication with the blood or fluid in the connected vessel, artery,organ or cavity and the transducer assembly 22 provides a continuousoutput signal indicative of the pressure of the fluid in the fluidchamber 14 of the percutaneous access port 10. In addition, the accessports 16 and 18 provide resealable access to the fluid chamber 14 by wayof the septum assembly 20 for injecting substances into the fluidchamber 14 or for injecting flushing substances into the fluid chamber14 for cleaning purposes.

In one preferred embodiment, the transducer assembly 22 is acommercially available transducer such as available from KonigsbergInstruments, Inc. of Pasadena, Calif., Kongisberg Model No. P5 and theend of the transducer cable 134 opposite the end of the transducer cable134 which is connected to the transducer assembly 22, is connectedthrough a temperature compensation circuit to a recorder (not shown) forrecording the monitored pressures. The septum assembly 20 may be any oneof the numerous septum commercially available which provide resealableaccess such as commercially available from Supelco, Inc. of Bellefonte,Pa. and referred to by Supelco as a Thermogreen Septa LB-2. The lowerbase 32, the disc 46, the cover 62 and the cap 86 each are constructedof a biocompatible plastic material. The plunger 124 preferably isconstructed of a stainless steel and the seal member 54 preferably isconstructed of a stainless steel with the spring 52 being constructed ofa silicone rubber biocompatible material. The connector 140 is a commonconnector for connecting tubing to the vessel or to an organ or to acavity in the body and with this type of connector which is commonlyused in the art the tubing is pressure fitted onto the connector 140.The tubing 142 may be in an artery, vessel, organ or cavity whereinjections, samples or pressure measurements may be required forevaluation and data collection.

When cover 62a is in place, pressure recordings can only be obtained byplacement of a needle through the access port, installation of astopcock device and use of a standard physiological transducer such asthose used in hospitals through I.V. tubing. Using this method thesubject can be monitored for pressure without the use of cover 62 whichhas the transducer installed. The physiological pressure transducer canbe utilized through the port holes 16 or 18 to receive a secondarypressure signal for a backup system and to test reliability of originalequipment.

EMBODIMENT OF FIG. 3

Shown in FIG. 3 is a modified percutaneous access port 10a which isconstructed exactly like the percutaneous access port 10, except thepercutaneous access port 10a does not include a transducer assembly suchas the transducer assembly 22 described before with respect to thepercutaneous access port 10. Thus, the percutaneous access port 10a willoperate in a manner exactly like that described before with respect tothe percutaneous access port 10, except the percutaneous access port 10adoes not have a transducer assembly for providing output signalsindicative of the pressure of the fluid in the fluid chamber 14.Pressure signals may only be obtained with the use of a standardphysiological transducer which has been connected by a needle throughthe injection port.

One advantage of the percutaneous access port 10 and 10a of the presentinvention is that the percutaneous access port 10 can be implanted in ananimal in a manner described before and can be readily modified withoutremoving the entire percutaneous access port 10 from the animal tomodify such port to the percutaneous access port 10a. To accomplishthis, the cover 62 is unthreaded from the lower base 32 of thepercutaneous access port 10 while in an implanted condition of thepercutaneous access port 10. As the cover 62 is unthreaded from thelower base 32, the plunger 124 is moved upwardly by the spring 52 andseal member 54 and the seal member 54 is moved into sealing engagementwith the sealing surface 44 of the lower base 32. Thus, when the cover62 has been removed from the percutaneous access port 10, the sealmember 54 sealing engages against the sealing surface 44 in the lowerbase 32 to sealingly close the opening 42 in the lower base 32. Thisprevents fluid from passing through the inlet port 30 and through theopening 42 in the lower base 32 after the cover 62 has been removed fromthe lower base 32. After the cover 62 has been removed from the lowerbase 32, then modified cover 62a is threaded onto the lower base 32 toprovide the modified percutaneous access port 10a shown in FIG. 4 andthis can be accomplished without removing the percutaneous access port10 or 10a of the present invention from the implanted condition in theanimal.

The access ports 16 and 18 provide easy access to the fluid chamber 14of either the percutaneous access port 10 or 10a for flushing,administering drugs, use of physiological transducer or withdrawingsamples from the fluid chamber 14. In a research situation whereinnumerous animals are monitored, one cover 62 with the transducerassembly 22 can be utilized to monitor a number of animals by simplyattaching this one cover to the implanted lower base 32 to form thepercutaneous access port 10 while the remaining lower bases havemodified cover 62a attached thereto to form the percutaneous access port10a. In addition, even with the cover 62 and transducer assembly 22connected to form the percutaneous access port 10, the access ports 16and 18 still are available for flushing, withdrawing samples,administering drugs and use of physiological transducer in the mannersdescribed before.

The tubing which is connected to the selected organ may be aMICRORENATHANE® type of tubing available from Braintree Scientic, Inc.of Braintree, Mass. This particular type of catheter tubing remainsflexible and can be heated in oil to draw its shape out to fit a smalltip or flange so it will remain within the body organ or cavity.

In preferred embodiment, an osmotic pump (not shown) also can beconnected to the tubing or catheter and implanted into the animal. Thispump is adapted to pump a heparin solution into the fluid chamber 14 forcontinuously flushing the fluid chamber 14. In normal operation, animplanted catheter has a life of about twelve days before clottingbegins. Using this pump for continuously flushing the system includingthe catheter, with heparinized saline, this life expectancy can beincreased substantially thereby further reducing technician handlingtime. One pump which would be suitable for use in connection with thepercutaneous access port 10 of the present invention in the manner justdescribed is available from Alzet Corporation of Palo Alto, Calif. andreferred to as the Alzet® osmotic pump.

In a preferred embodiment, the body organ connected to the inlet port 30of the present invention is a sexual organ of a male or female subjectas shown in FIGS. 5-8. The distal end of the tubing (shown in dashedlines in FIGS. 1 and 4) is positioned in the sexual organ so that thefluid chamber 14 and the inlet port 30 are in fluid communication withthe sexual organ namely, a pregnant or non-pregnant uterus U, or anamnion A in the pregnant uterus U, as shown in FIGS. 5 and 6,respectively, or a male sexual organ, namely, either a scrotum S or apenis P, as shown in FIGS. 8 and 9, respectively.

Once fluid communication is established, agents may be disposed to thebody organ by disposing the agent in the fluid chamber 14 and flushingthe fluid chamber with a sufficient amount of flushing solution todeposit the agent in the sexual organ.

In the female subject, the percutaneous access port 10 may be implantedat any location near the uterine wall as previously described so that anincision can be made in the uterine wall for the inlet port to bepositioned therethrough (FIGS. 5-6). The percutaneous device may also beimplanted near the vaginal canal so that the tubing can be positionedthrough the vaginal canal into the uterus. This method may be preferredin humans or expensive animals such as horses or cows since it is a lessinvasive procedure. The implantation of the device can occur before orafter the subject becomes pregnant, unless the amnion or the fetal bloodvessels are to be connected to the inlet port, then the subject must bein a pregnant condition. Once implanted, the percutaneous access port ofthe present invention can remain in the subject throughout one orseveral pregnancies.

Any selected agent may be disposed in the body organ, preferably thesexual organ, in accordance with the present invention. The agent may bea drug or other substance to treat the sexual organ, the subjectsystemically or a fetus contained within the sexual organ. The drug mayalso be a hormone or other substance used to treat infertility or forbirth control purposes in the male or female subject. The agent may alsobe a zygote or sperm to impregnate the female subject.

The agent is disposed in the fluid chamber 14 by injecting the agent viaports 16 or 18. The agent may also be infused into the fluid chamber 14over a period of time by an infusion pump (not shown). A physiologicallyacceptable flushing solution compatible with the agent, such as normalsaline, is injected via ports 16 or 18 into the fluid chamber insufficient quantity to flush the agent through the percutaneous accessport into the organ or cavity.

A fetus in the uterus can be monitored in accordance with the presentinvention by connecting the transducer assembly 22 as previouslydescribed to the percutaneous access port 10. The transducer senses thepressure exerted on intrauterine fluid, amniotic fluid or fetal blood bythe fetus, depending upon where the distal end of the tubing ispositioned. The pressure exerted on the intrauterine fluid and theamniotic fluid is indicative of the blood pressure of the fetus as wellas any activity of the fetus and thus is an effective way to monitor thewell-being of the fetus and to study teratogenic effects of agents givento the mother.

One of the advantages of the present invention is that this one device,the percutaneous access port, can measure the blood pressure andactivity of the fetus, collect fluid samples and deposit agents in thesexual organ or the fetus. This can be invaluable when studying theteratogenic effects of agents on the fetus. Additionally, the presentinvention can be used to impregnate a female subject, monitor thepregnancy and treat the fetus in utero. The same device can be used toprevent pregnancy in female subjects by disposing the appropriatehormones or agents.

Once the present invention is in fluid communication with the selectedbody organ, preferably a body cavity or any body part having fluidtransferable through the percutaneous access port, a sample may bewithdrawn from the fluid chamber. The sample may be withdrawn byinserting a needle attached to a syringe through the access ports andwithdrawing fluid into the syringe. The sample is contained in the fluidand is sized to travel through the percutaneous access port to the fluidchamber 14. The sample may be any substance dissolved or suspended influid in the body organ. Examples of samples are eggs, and endogenousand exogenous chemical substances.

The subject in the method of the present invention may be any suitableliving object. Some examples of subjects in the method of the presentinvention are humans, horses, cattle, sheep, rats, mice and ferrets.Preferably, mammals are the subjects of the present invention, and morepreferably humans.

Changes may be made in the construction and operation of the variouselements, parts and assembly described herein and changes may be made inthe steps or the sequence of steps of the methods described hereinwithout departing from the spirit and scope of the invention as definedin the following claims.

What is claimed is:
 1. A method for both disposing an agent in a sexualorgan of a human or an animal and retrieving a fluid sample containingthe agent from the sexual organ of the human or animal, comprising thesteps of:implanting in the human or the animal a portion of apercutaneous access port, wherein said portion of the percutaneousaccess port is implanted into a sexual organ in the human or animal,said percutaneous access port comprising:a base assembly having an upperend, a lower end, and an outer peripheral surface, wherein the upper endfurther comprises a removable and replaceable cover, and wherein thelower end further comprises a lower base, the cover connectinglyengageable and releasable from the lower base, the cover being disposedabove the skin surface, a portion of the lower base percutaneouslyimplanted; a single accessible fluid chamber formed within the baseassembly, the fluid chamber formed when both the cover and the lowerbase are connected together, a portion of the fluid chamber formed bythe cover and a portion of the fluid chamber formed by the lower base,the fluid chamber selectively accessible when the cover is connected tothe lower base; sealing means contained within the lower base, saidsealing means controlled by connecting and disconnecting the cover, thesealing means controlling fluidic access to fluid contained in the lowerbase of the percutaneous access port when the cover is removed, whereinthe fluid chamber is formed and the fluid contained therein isaccessible when the cover is connected to the lower base, and whereinthe fluid chamber is disassembled and the fluid in the lower base isinaccessible when the cover is removed from the lower base; an accessport formed within the cover, wherein said access port has a septumassembly which extends across and covers said access port, said accessport in fluidic communication with said fluid chamber when the cover isconnected to the lower base, wherein said septum assembly permitsresealable access via a needle to said fluid chamber; an inlet portformed in a portion of the lower base, the inlet port in communicationwith the fluid chamber when the cover is connected to the lower base,the inlet port connectable to the sexual organ; wherein the inlet portand a portion of the lower base is percutaneously implanted in thesexual organ of the human or the animal, said inlet port in fluidiccommunication with the sexual organ of the human or animal, said inletport also in fluidic communication with said fluid chamber when thecover is connected to the lower base; connecting the sexual organ of thehuman or the animal capable of having fluid flow therethrough to theinlet port of the percutaneous access port so that fluid contained inthe sexual organ is in fluidic communication with the fluid chamber inthe percutaneous access port when the cover of the base assembly isconnected to the lower base of the base assembly; disposing the agentvia the access port in the cover into the fluid chamber of thepercutaneous access port; flushing the agent into the sexual organ bydelivering via the access port in the cover an effective amount offlushing solution to flush the agent through the percutaneous accessport and deliver the agent to the sexual organ; withdrawing at a latertime from the percutaneous access port the fluid sample containing theagent by accessing the fluid chamber via the access port in the cover;and determining the amount of the agent in the sample.
 2. The method ofclaim 1 wherein the sexual organ is a uterus.
 3. The method of claim 2wherein the agent is a zygote.
 4. The method of claim 2 wherein theagent is sperm.
 5. The method of claim 2 wherein the uterus contains afetus.
 6. The method of claim 1 wherein the agent is a drug.
 7. Themethod of claim 6 wherein the drug is a hormone.
 8. The method of claim1 wherein the sexual organ is a male sexual organ.
 9. A method forobtaining a sample transported in fluid received in a percutaneousaccess port from a body organ or a human or an animal, comprising thesteps of:implanting in the human or the animal a portion of apercutaneous access port, wherein said portion of the percutaneousaccess port is implanted into a body organ in the human or animal, saidpercutaneous access port comprising:a base assembly having an upper end,a lower end, and an outer peripheral surface, wherein the upper endfurther comprises a removable and replaceable cover, and wherein thelower end further comprises a lower base, the cover connectinglyengageable and releasable from the lower base, the cover being disposedabove the skin surface, a portion of the lower base percutaneouslyimplanted; a single accessible fluid chamber formed within the baseassembly, the fluid chamber formed when both the cover and the lowerbase are connected together, a portion of the fluid chamber formed bythe cover and a portion of the fluid chamber formed by the lower base,the fluid chamber selectively accessible when the cover is connected tothe lower base; sealing means contained within the lower base, saidsealing means controlled by connecting and disconnecting the cover, thesealing means controlling fluidic access to fluid contained in the lowerbase of the percutaneous access port when the cover is removed, whereinthe fluid chamber is formed and the fluid contained therein isaccessible when the cover is connected to the lower base, and whereinthe fluid chamber is disassembled and the fluid in the lower base isinaccessible when the cover is removed from the lower base; an accessport formed within the cover, wherein said access port has a septumassembly which extends across and cover said access port, said accessport in fluidic communication with said fluid chamber when the cover isconnected to the lower base, wherein said septum assembly permitsresealable access via a needle to said fluid chamber; an inlet portformed in a portion of the lower base, the inlet port in communicationwith the fluid chamber when the cover is connected to the lower base,the inlet port connectable to the body organ; wherein the inlet port anda portion of the lower base is percutaneously implanted in the bodyorgan of the human or the animal, said inlet port in fluid communicationwith the body organ of the human or animal, said inlet port also influidic communication with said fluid chamber when the cover isconnected to the lower base; connecting the body organ of the human orthe animal capable of having fluid flow therethrough to the inlet portof the percutaneous access port so that fluid contained in the bodyorgan is in fluidic communication with the fluid chamber in thepercutaneous access port when the cover of the base assembly isconnected to the lower base of the base assembly; andwithdrawing fluidcontaining the sample by accessing the fluid chamber via the access portin the cover.
 10. The method of claim 9 wherein a plurality of samplesis withdrawn from the fluid chamber.
 11. The method of claim 9 whereinthe body organ is a blood vessel and the fluid is blood.
 12. The methodof claim 9 wherein the body organ is a pregnant uterus, the inlet portbeing in communication with an amnion in the uterus, and the fluidsample comprises amniotic fluid.
 13. The method of claim 9 furthercomprising:disposing an agent in the fluid chamber; and flushing thepercutaneous access port with an effective amount of flushing solutionto deliver the agent to the body organ.
 14. The method of claim 13wherein the agent is a drug.
 15. A method for retrieving an agent in asample transported in fluid, the sample received in a percutaneousaccess port from a body organ of a subject, comprising the stepsof:implanting in the human or the animal a portion of a percutaneousaccess port, wherein said portion of the percutaneous access port isimplanted into a body organ in the human or animal, said percutaneousaccess port comprising:a base assembly having an upper end, a lower end,and an outer peripheral surface, wherein the upper end further comprisesa removable and replaceable cover, and wherein the lower end furthercomprises a lower base, the cover connectingly engageable and releasablefrom the lower base, the cover being disposed above the skin surface, aportion of the lower base percutaneously implanted; a single accessiblefluid chamber formed within the base assembly, the fluid chamber formedwhen both the cover and the lower base are connected together, a portionof the fluid chamber formed by the cover and a portion of the fluidchamber formed by the lower base, the fluid chamber selectivelyaccessible when the cover is connected to the lower base; sealing meanscontained within the lower base, said sealing means controlled byconnecting and disconnecting the cover, the sealing means controllingfluidic access to fluid contained in the lower base of the percutaneousaccess port when the cover is removed, wherein the fluid chamber isformed and the fluid contained therein is accessible when the cover isconnected to the lower base, and wherein the fluid chamber isdisassembled and the fluid in the lower base is inaccessible when thecover is removed from the lower base; an access port formed within thecover, wherein said access port has a septum assembly which extendsacross and cover said access port, said access port in fluidiccommunication with said fluid chamber when the cover is connected to thelower base, wherein said septum assembly permits resealable access via aneedle to said fluid chamber; an inlet port formed in a portion of thelower base, the inlet port in communication with the fluid chamber whenthe cover is connected to the lower base, the inlet port connectable tothe body organ; wherein the inlet port and a portion of the lower baseis percutaneously implanted in the body organ of the human or theanimal, said inlet port in fluidic communication with the body organ ofthe human or animal, said inlet port also in fluidic communication withsaid fluid chamber when the cover is connected to the lower base;connecting the body organ of the human or the animal capable of havingfluid flow therethrough to the inlet port of the percutaneous accessport so that fluid contained n the body organ is in fluidiccommunication with the fluid chamber in the percutaneous access portwhen the cover of the base assembly is connected to the lower base ofthe base assembly; and withdrawing fluid containing the sample byaccessing the fluid chamber via the access port in the cover; anddetermining the amount of the agent in the sample.
 16. The method ofclaim 15 wherein a plurality of samples is withdrawn from the fluidchamber.
 17. The method of 15 wherein the body organ is a blood vesseland the fluid is blood.
 18. The method of claim 15 wherein the bodyorgan is a uterus containing a fetus and the fluid sample is amnioticfluid.
 19. The method of claim 15 wherein the agent is a drug.
 20. Themethod of claim 15 wherein the agent is a hormone.